Biotechnology
CARsgen Submits Dual IND Applications for Allogeneic BCMA CAR-T Product CT0596
SHANGHAI, Dec. 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administr...
2025-12-29 08:10
China's First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent's TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval
* TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. * The TABOSUN® and TYVYT® c...
2025-12-25 16:45
698
Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies
* Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of CBL-514 for weight management (CBL-0201WR Phase 2). * The study will evaluate CBL-514 in combination with Zepbound® (Eli Lilly) in...
2025-12-25 10:05
582
Mabwell Receives IND Clearance for Novel Anti-ST2 Monoclonal Antibody 9MW1911 to Initiate Phase IIa Study
SHANGHAI, Dec. 24, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that it has received IND clearance from the U.S. Food and Drug Administration (FDA) for its self-developed anti-ST2 monoclonal antibody (R&...
2025-12-24 22:00
669
Nona Biosciences Expands Integrated Discovery-to-Clinical Capabilities Through Strategic Platform Growth
CAMBRIDGE, Mass., Dec. 23, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company advancing biotherapeutic discovery through innovative technology platforms, today announced the expansion of its integrated discovery and development framework to support early clinical development an...
2025-12-24 09:20
1099
SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug 'SNB-101' on Gastric Cancer.
SEONGNAM, South Korea, Dec. 23, 2025 /PRNewswire/ -- SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) onDecember 10 for gastric cancer (including gastroesophageal junction cancer) to SNB-101 (API: SN-38) which is a polymer nanoparticle drug...
2025-12-24 07:37
1088
Senhwa Biosciences Highlights AI-Validated Oncology Platform and Strategic Clinical Collaborations Targeting Next-Generation Immuno-Oncology products at Its 2025 Annual Investor Conference
TAIPEI and SAN DIEGO, Dec. 23, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage companies focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today outlined continued progress across its AI-enabled drug developm...
2025-12-23 20:00
2103
Fapon Biopharma Publishes Pioneering Research in Cell Reports Medicine on FP008, an anti-PD 1 X IL-10M Fusion Protein for Cancer Immunotherapy
DONGGUAN, China, Dec. 23, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech in developing therapeutic biologics including cytokine-antibody fusion proteins and T-cell engagers, announced the publication of pioneering research on FP008, a novel fusion protein inCell Reports Medicine. The peer-review...
2025-12-23 13:03
2180
Origin Agritech Holds Annual R&D and Operations Management Conference, Establishes 2026 Strategic Priorities
BEIJING, Dec. 22, 2025 /PRNewswire/ -- Origin Agritech Ltd. (NASDAQ: SEED) (the "Company" or "Origin"), a leading Chinese agricultural technology company, announced the results of its Annual Research & Development and Operations Management Conference held at the Company'sBeijing headquarters from...
2025-12-22 21:36
2276
Kazia Therapeutics Regains Full Nasdaq Listing Compliance
Restoration of Nasdaq compliance follows $50 million institutional financing and reinforces balance-sheet strength SYDNEY, Dec. 22, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA), a clinical-stage oncology company focused on developing innovative therap...
2025-12-22 21:00
2828
T-MAXIMUM Pharmaceutical's Allogeneic CAR-T Therapy MT027 Receives FDA IND Clearance to Proceed to Phase II clinical Trial for Recurrent Glioblastoma
BEIJING, Dec. 21, 2025 /PRNewswire/ -- T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial for the treatment of recurrent glioblas...
2025-12-21 20:20
2249
WuXi Biologics Achieves CDP Highest "A" Ratings in Both Climate Change and Water Security
SHANGHAI, Dec. 19, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK) announced that it has been named to the CDP "A" lists for both Climate Change and Water Security for 2025, underscoring its leadership in environmental stewardship and transparent disclosure. Climate Change Leadership Being recogn...
2025-12-19 17:30
3590
NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of the National Medical Products Administration ("NM...
2025-12-19 09:46
3496
Freda Key C Presents Advanced Recombinant Collagen Delivery Technology at SCC79
Novel Delivery System for High-Molecular-Weight Collagen Advances Anti-Aging Science at the Society of Cosmetic Chemists' Annual Meeting NEW YORK, Dec. 18, 2025 /PRNewswire/ -- Shandong Freda Biotech Co., Ltd. and its medical-aesthetic skincare brand Key C announced the presentation of a novel c...
2025-12-18 22:00
2710
CorestemChemon Advances Toward ALS Stem Cell Commercialization with Regulatory Progress in Korea and NSF-Backed U.S. Expansion
SEOUL, South Korea, Dec. 17, 2025 /PRNewswire/ -- CorestemChemon (KOSDAQ: 166480)is entering a critical late-stage phase in the commercialization of its ALS stem cell therapy, Neuronata-R. The company attributes this momentum to advanced domestic regulatory review in Korea, entry into an NSF-supp...
2025-12-18 10:31
1113
Nature | Two Phase 3 Clinical Results of Mazdutide (GLP-1/GCG Dual Receptor Agonist) in Chinese Adults with Type 2 Diabetes Have Been Back-to-Back Published in Nature
SAN FRANCISCO and SUZHOU, China, Dec. 17, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metaboli...
2025-12-18 08:00
1820
PRISM BioLab and Talus Bioscience Join Forces to Discover Novel Inhibitors of Transcription Factor and Protein-Protein Interaction Targets
TOKYO, Dec. 17, 2025 /PRNewswire/ -- PRISM BioLab, Co. Ltd. ("PRISM") and Talus Bioscience, Inc. ("Talus Bio") announced today that they entered into a collaboration to discover novel Inhibitors of transcription factor (TF) and protein-protein interaction (PPI) targets. By combining Talus Bio's a...
2025-12-18 00:00
2310
MEDI&GENE Announces Catalyze Agreement with Lilly to Advance Next-Generation Obesity Therapeutics
SEOUL, South Korea, Dec. 17, 2025 /PRNewswire/ -- MEDI&GENE, a
biopharmaceutical company developing therapeutics for metabolic diseases,
announced today that it has entered into a Catalyze agreement with
Eli Lilly and Company (Lilly) to advance a next-generation therapeutic for
obesity.
2025-12-17 21:00
1991
BioTec Sets New Market Standards with Fusion-Based Bio Solutions, Aiming for Global Expansion
SEOUL, South Korea, Dec. 16, 2025 /PRNewswire/ -- BioTec's new releases are attracting attention as technology-fusion solutions rarely seen in the current market. The company's supplement developed with processed sulfur and microbial fermentation offers improved gut health and immune support for ...
2025-12-17 12:10
1301
Harbour BioMed Enters into Global Strategic Collaboration and License Agreement with Bristol Myers Squibb to Discover and Develop Next-Generation Multi-Specific Antibodies
SHANGHAI, CAMBRIDGE, Mass. and ROTTERDAM, Netherlands, Dec. 16, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced amulti-year, global strategi...
2025-12-17 08:04
611
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